What do patients with heart failure disclose about medication adherence at home to their hospital and primary care doctors? Exploratory interaction-based observational cohort study.

OBJECTIVES: The main objective of this study was twofold: to investigate what kind of information patients with heart failure (HF) tell their doctors about their medication adherence at home, and how often such information is provided in consultations where medication reconciliation is recommended. To meet these objectives, we developed an analysis to recognise, define, and count (1) patient utterances including medication adherence disclosures in clinical interactions (MADICI), (2) MADICI including red-flags for non-adherence, and (3) MADICI initiated by patients without prompts from their doctor. DESIGN: Exploratory interaction-based observational cohort study. Inductive microanalysis of authentic patient-doctor consultations, audio-recorded at three time-points for each patient: (1) first ward visit in hospital, (2) discharge visit from hospital, and (3) follow-up visit with general practitioner (GP). SETTING: Norway (2022-2023). PARTICIPANTS: 25 patients with HF (+65 years) and their attending doctors (23 hospital doctors, 25 GPs). RESULTS: We recognised MADICI by two criteria: (1) they are about medication prescribed for use at home, AND (2) they involve patients' action, experience, or stance regarding medications. Using these criteria, we identified 427 MADICIs in 25 patient trajectories: 143 (34%) at first ward visit (min-max=0-35, median=3), 57 (13%) at discharge visit (min-max=0-8, median=2), 227 (53%) at GP-visit (min-max=2-24, median=7). Of 427 MADICIs, 235 (55%) included red-flags for non-adherence. Bumetanide and atorvastatin were most frequently mentioned as problematic. Patients initiated 146 (34%) of 427 MADICIs. Of 235 'red-flag MADICIs', 101 (43%) were initiated by patients. CONCLUSIONS: Self-managing older patients with HF disclosed information about their use of medications at home, often including red-flags for non-adherence. Patients who disclosed information that signals adherence problems tended to do so unprompted. Such disclosures generate opportunities for doctors to assess and support patients' medication adherence at home.

Receipt of hepatitis E vaccine and fetal loss in rural Bangladesh: further analysis of a double-blind, cluster-randomised, controlled trial.

BACKGROUND: Vaccination constitutes an attractive control measure for hepatitis E virus (HEV), a major cause of maternal and perinatal mortality globally. Analysis of pregnant participants in an effectiveness trial of the HEV vaccine HEV239 showed possible HEV239-associated fetal losses. We aimed to conduct a detailed analysis of this safety signal. METHODS: In a double-blind, cluster-randomised trial, 67 villages in Matlab, Bangladesh, were randomly allocated (1:1) to two vaccine groups, in which non-pregnant women aged 16-39 years received either HEV239 (HEV239 group) or Hepa-B (a hepatitis B vaccine; control group). We implemented weekly surveillance for pregnancy detection, and follow-up of pregnancies once every 2 weeks, using physician-confirmed diagnoses to evaluate fetal loss outcomes (miscarriage [spontaneous abortion], stillbirth, and elective termination). Data from a parallel system of reproductive health surveillance in Matlab were used to clarify study diagnoses when necessary. Miscarriage was assessed only among participants whose first positive pregnancy test and vaccination date (for whichever dose was closest to the date of last menstrual period [LMP]) were before 20 weeks' gestation. We defined the following analysis periods of interest: from 90 days before the LMP until the pregnancy outcome (the proximal period); from the LMP date until the pregnancy outcome (the pregnancy period); from 90 days before the LMP until the LMP date (90 days pre-LMP period); and from enrolment until 90 days before the LMP (the distal period). Both Poisson and Cox regression models were used to assess the associations between receipt of HEV239 and fetal loss outcomes. The trial was registered with ClinicalTrials.gov (NCT02759991). FINDINGS: Among the 19 460 non-pregnant participants enrolled in the trial, 5011 were identified as having pregnancies within 2 years following vaccination and met the criteria for analysis (2407 in the HEV239 group and 2604 in the control group). Among participants vaccinated in the proximal period and evaluated for miscarriage, miscarriage occurred in 54 (8·9%) of 607 in the HEV239 group and 32 (4·5%) of 719 in the control group (adjusted relative risk [aRR] 2·0 [95% CI 1·3-3·1], p=0·0009). Similarly, the risk of miscarriages was increased in the HEV239 group versus the control group among participants inadvertently vaccinated during pregnancy (22 [10·5%] miscarriages among 209 participants in the HEV239 group vs 14 [5·3%] of 266 in the control group; aRR 2·1 [95% CI 1·1-4·1], p=0·036) and among those vaccinated within 90 days pre-LMP (32 [8·0%] of 398 vs 18 [4·0%] of 453; 1·9 [1·1-3·2], p=0·013). No increased risk of miscarriage was observed in those who received HEV239 in the distal period (93 [5·6%] of 1647 vs 80 [4·5%] of 1773; 1·3 [0·8-1·9], p=0·295). Stillbirth and elective termination showed no increased risk among women administered HEV239 versus those administered Hepa-B in any of the analysis periods. INTERPRETATION: HEV239 given shortly before or during pregnancy was associated with an elevated risk of miscarriage. This association poses a possible safety concern for programmatic use of HEV239 in women of childbearing age. FUNDING: Research Council of Norway and Innovax.

Short-term association between air temperature and mortality in seven cities in Norway: A time series analysis.

BACKGROUND: The association between ambient air temperature and mortality has not been assessed in Norway. This study aimed to quantify for seven Norwegian cities (Oslo, Bergen, Stavanger, Drammen, Fredrikstad, Trondheim and Tromsø) the non-accidental, cardiovascular and respiratory diseases mortality burden due to non-optimal ambient temperatures. METHODS: We used a historical daily dataset (1996-2018) to perform city-specific analyses with a distributed lag non-linear model with 14 days of lag, and pooled results in a multivariate meta-regression. We calculated attributable deaths for heat and cold, defined as days with temperatures above and below the city-specific optimum temperature. We further divided temperatures into moderate and extreme using cut-offs at the 1st and 99th percentiles. RESULTS: We observed that 5.3% (95% confidence interval (CI) 2.0-8.3) of the non-accidental related deaths, 11.8% (95% CI 6.4-16.4) of the cardiovascular and 5.9% (95% CI -4.0 to 14.3) of the respiratory were attributable to non-optimal temperatures. Notable variations were found between cities and subgroups stratified by sex and age. The mortality burden related to cold dominated in all three health outcomes (5.1%, 2.0-8.1, 11.4%, 6.0-15.4, and 5.1%, -5.5 to 13.8 respectively). Heat had a more pronounced effect on the burden of respiratory deaths (0.9%, 0.2-1.0). Extreme cold accounted for 0.2% of non-accidental deaths and 0.3% of cardiovascular and respiratory deaths, while extreme heat contributed to 0.2% of non-accidental and to 0.3% of respiratory deaths. CONCLUSIONS: Most of the burden could be attributed to the contribution of moderate cold. This evidence has significant implications for enhancing public-health policies to better address health consequences in the Norwegian setting.

Impact of the ESC Cardio-Oncology Guidelines Biomarker Criteria on Incidence of Cancer Therapy-Related Cardiac Dysfunction.

Background: The impact of recent consensus definitions of cancer therapy-related cardiac dysfunction (CTRCD) from the European Society of Cardiology cardio-oncology guidelines on the reported incidence of CTRCD has not yet been assessed. Objectives: The aim of this study was to assess the: 1) cumulative incidence; 2) point prevalence during and after adjuvant therapy; and 3) prognostic value of CTRCD as defined by different asymptomatic CTRCD guideline criteria. Methods: The cumulative incidence and point prevalence of CTRCD were retrospectively assessed in 118 patients participating in the PRADA (Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy) trial. Asymptomatic CTRCD was assessed using alternative cardiac troponin (cTn) 99th percentile upper reference limits (URLs) to define cTnT and cTnI elevation. Results: The cumulative incidence of moderate or severe CTRCD was low (1.7%), whereas the cumulative incidence of mild asymptomatic CTRCD was higher and differed markedly according to the biomarker criteria applied, ranging from 49.2% of patients when cTnT greater than the sex-specific 99th percentile URL was used to define cTn elevation to 9.3% when sex-neutral cTnI was used. The point prevalence of CTRCD was highest at the end of anthracycline therapy (47.8%) and was driven primarily by asymptomatic cTn elevation. CTRCD during adjuvant therapy was not prognostic for CTRCD at extended follow-up of 24 months (Q1-Q3: 21-29 months) after randomization. Conclusions: Mild asymptomatic CTRCD during adjuvant breast cancer therapy was frequent and driven mainly by cTn elevation and was not prognostic of subsequent CTRCD. The incidence of mild, asymptomatic CTRCD differed markedly depending on the cTn assay and whether sex-neutral or sex-dependent URLs were applied. (Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy [PRADA]; NCT01434134).

Completeness of medication information in admission notes from emergency departments.

BACKGROUND: Medication lists prepared in the emergency department (ED) form the basis for diagnosing and treating patients during hospitalization. Since incomplete medication information may lead to patient harm, it is crucial to obtain a correct and complete medication list at hospital admission. In this cross-sectional retrospective study we wanted to explore medication information completeness in admission notes from Norwegian EDs and investigate which factors were associated with level of completeness. METHODS: Medication information was assessed for completeness by applying five evaluation criteria; generic name, formulation, dose, frequency, and indication for use. A medication completeness score in percent was calculated per medication, per admission note and per criterion. Quantile regression analysis was applied to investigate which variables were associated with medication information completeness. RESULTS: Admission notes for patients admitted between October 2018 and September 2019 and using at least one medication were included. A total of 1,080 admission notes, containing 8,604 medication orders, were assessed. The individual medications had a mean medication completeness score of 88.1% (SD 16.4), while admission notes had a mean medication completeness score of 86.3% (SD 16.2). Over 90% of all individual medications had information about generic name, formulation, dose and frequency stated, while indication for use was only present in 60%. The use of an electronic tool to prepare medication information had a significantly strong positive association with completeness. Hospital visit within the last 30 days, the patient's living situation, number of medications in use, and which hospital the patient was admitted to, were also associated with information completeness. CONCLUSIONS: Medication information completeness in admission notes was high, but potential for improvement regarding documentation of indication for use was identified. Applying an electronic tool when preparing admission notes in EDs seems crucial to safeguard completeness of medication information.